SUPPLY CHAIN ARTICLES

  • What Violin Making Can Teach Us About mRNA Therapeutic Quality

    Managing the mRNA supply chain and working in mRNA process development may not look anything like the work a luthier does to hew an instrument from an ancient spruce tree. But violin craftmanship actually serves as a fantastic metaphor for the challenging work the mRNA therapeutics space is tackling in sourcing and qualifying raw materials and optimizing the critical IVT reaction.

  • Multidisciplinary mRNA: What Can We Learn From Other CGTs?

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

  • 4 Risk Mitigation Strategies For mRNA Production

    Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

  • The Expanding Patent Landscape For RNA-Based Therapeutics

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

SUPPLY CHAIN VIDEOS

The mRNA supply chain is undergoing massive growth in three particular areas. Here, speakers Khaled Yamout & Francoise Ribes walk us through the materials that have undergone the most scientific growth over the past few years and the impacts they’re noting these advancements having on the development of our mRNA drug substances and mRNA-LNP drug products. 

In this clip, Sanofi’s Greg Troiano kickstarts our discussion on some of the advances he’s seen in the supply chain for linear mRNA-LNP products, both in terms of supply availability and supplier capability.

There remain a lot of gaps in our understanding of plasmid quality, particularly for high-quality mRNA production (as opposed to viral vector production). In this segment of a recent Advancing RNA Live panel, speakers Adi Nair, Tyler Goodwin, and April Sena highlight their biggest questions around plasmid DNA quality, as well as the pros and cons of some of the analytical methods upon which we’re relying most heavily today to assess plasmid quality.

As CRISPR technology evolves beyond the original Cas9, gRNAs are transitioning from simple targeting tools into highly engineered, complex molecules. In this Advancing RNA Live segment, speakers April Sena, Max De Long, and Venkat Krishnamurthy discuss how the rise of diverse nucleases — including prime editors — is impacting gRNA synthesis and purity.

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